Medical devices for delivering therapeutic energy such as electrical pulses to tissue include one or more electrodes and a pulse generator. The pulse generator allows the electrode to deliver the therapeutic energy to a targeted tissue, thereby causing ablation of the tissue.
Electroporation procedure parameters that influence the size and shape of their affected region include the nature of the tissue (cellularity, extracellular constituent composition, anisotropy, conductivity, metabolic demand), patient specific anatomy, the pulse delivery apparatus (number of electrodes, their size, and relative geometry), and pulse parameters (voltage, number of pulses, pulse length, pulse delivery rate). In addition to the above, the generator's maximum pulse intensity capabilities (maximum voltage and current) dictate the maximum achievable treatment region. Where controllable and large lesions are desired, it is important to maintain pulses that are capable of inducing electroporation effects to the tissue while remaining below the maximum generator capacity.
In conventional electroporation devices, before the treatment procedure a physician would decide on a particular pulse delivery apparatus and select the pulse parameters. As can be appreciated, the electroporation therapy treatment plans selected by the physician are limited to using a retrospective dimension data approach, where a pre-determined pulse parameter protocol is delivered between each electrode pair in an array and the pulse parameters are selected from previously existing ablation data. Once the treatment procedure starts, the electroporation device follows the pre-treatment programming set by the physician and delivers the pulses according to the pre-selected pulse parameters.
However, this approach ignores the specifics of the actual case, which will vary both in terms of initial tissue properties and tissue response to the electroporation pulses for each patient. Specifically, there is no way to monitor the progress of the treatment procedure or alter the settings other than to stop the procedure manually. Thus, even when the procedure completes normally, there was no assurance that there were clinically sufficient electroporation of the targeted region due to the unpredictable nature of patient environments and living tissue.
Therefore, it would be desirable to provide a system and method for monitoring the progress of an electroporation treatment procedure in real-time and to determine in real-time whether an end point has been reached for particular patients.